Health Canada talks of opening up ‘black box of medicines’ safety’

Canadians could be a step closer to being able to access sensitive information about the safety of drugs and medical devices.

On Friday, Health Canada published a white paper on opening up clinical information on drug safety to the public.

It could be the beginning of a fundamental change to Health Canada’s longstanding practice of treating clinical trial data as confidential drug company secrets, said Prof. Matthew Herder, director of the Health Law Institute at Dalhousie University in Halifax.

“When companies would put a confidential stamp on top of that stack of information, the regulator just accepted that claim. So it’s very hard to change an institution’s culture. I think Health Canada is finally listening to Canadians,” Herder said in an interview.

Without knowing the unpublished drug safety information, patients and their doctors have at best half the picture and at worst are misled, Herder said.

So far, the process of getting drug safety information from Health Canada is “extremely frustrating,” compared with the access the European medicines regulator provides, said Dr. Nav Persaud.

Persaud, a staff physician at Toronto’s St. Michael’s Hospital, fought for four years to gain access to some unpublished clinical trial information from Health Canada’s files about a commonly prescribed morning sickness pill.

Persuad had to sign a confidential agreement to see the data. He can share his interpretations of it, but not the raw data itself or Health Canada could sue.

“There’s actually nothing that we’ll lose by opening up access to this information and I think it’s the expectation of every person who has taken a medication or contemplated taking a medication that they’ll have access to all of the information that they need,” Persaud said.

Herder and Persaud welcomed Health Canada’s move to consider greater transparency but wonder how much longer it will take.

Herder is concerned about the long regulatory road still ahead to open up what he and his co-authors have called the “black box of medicines’ safety in Canada.”

Herder is also part of a group of professors who are taking Health Canada to federal court, saying the regulator’s requirements for confidentiality agreements go too far to protect drug company secrets.